Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Obstetrics & Gynecology ×
4,525 results
1009–1032 of 4,525
Search insights Median review: 111d Cleared: 100% Top manufacturer: Tambrands, Inc. Lead specialty: Obstetrics & Gynecology
Cleared Jun 20, 2014
THERMEDX FLUID MANAGMENT SYSTEM
K133799 · HIG
Thermedx, LLC
Obstetrics & Gynecology · 189d
Cleared Jun 18, 2014
QUALIS
K133295 · MQK
Menicon Co., Ltd. New Business Division
Obstetrics & Gynecology · 236d
Cleared Jun 16, 2014
EMBRYOGEN
K140317 · MQL
Origio A/S
Obstetrics & Gynecology · 126d
Cleared Jun 11, 2014
JO PREMIUM PERSONAL LUBRICANT
K132954 · NUC
United Consortium
Obstetrics & Gynecology · 264d
Not Cleared Jun 06, 2014
EEVA 2.0
DEN120015 · PBH
Auxogyn, Inc.
Obstetrics & Gynecology · 651d
Cleared Jun 04, 2014
PANPAC INFLATABLE DOCUT PESSARY
K132670 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 281d
Cleared May 29, 2014
KOALA TOCO
K140163 · HFM
Clinical Innovations, LLC
Obstetrics & Gynecology · 127d
Cleared May 28, 2014
CLEARVIEW TOTAL
K131781 · LKF
Clinical Innovations, LLC
Obstetrics & Gynecology · 345d
Cleared May 27, 2014
ACESSA GUIDANCE SYSTEM
K132744 · HFG
Halt Medical, Inc.
Obstetrics & Gynecology · 266d
Cleared May 16, 2014
BIOPSY PIPETTES
K133257 · MQH
Research Instruments , Ltd.
Obstetrics & Gynecology · 205d
Cleared May 15, 2014
FETAL MONITORS
K131941 · HGM
Guangdong Biolight Meditech Co., Ltd.
Obstetrics & Gynecology · 322d
Cleared May 14, 2014
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO...
K133912 · MQL
Origio A/S
Obstetrics & Gynecology · 142d
Cleared May 13, 2014
VERSACUT + TISSUE MORCELLATOR
K133272 · GCJ
Lumenis, Ltd.
Obstetrics & Gynecology · 201d
Cleared May 07, 2014
Origio Gas Line Filter
K132870 · MQG
Origio, Inc.
Obstetrics & Gynecology · 236d
Cleared May 01, 2014
SUSTAIN
K131866 · HIS
Hollender Sustainable Brands, LLC
Obstetrics & Gynecology · 311d
Cleared Apr 29, 2014
ORIGIO(R) SEQUENTIAL BLAST TM
K133387 · MQL
Origio A/S
Obstetrics & Gynecology · 175d
Cleared Apr 28, 2014
ACESSA GUIDANCE HANDPIECE
K132184 · HFG
Halt Medical, Inc.
Obstetrics & Gynecology · 287d
Cleared Apr 28, 2014
BRELLA-SPEC(TM) VAGINAL SPECULUM
K133857 · HIB
Proa Medical, Inc.
Obstetrics & Gynecology · 130d
Cleared Apr 24, 2014
ELECTRIC BREAST PUMP
K132882 · HGX
Shantou Xinghe Electrical Apparatuses...
Obstetrics & Gynecology · 223d
Cleared Apr 23, 2014
EUM 100PRO
K131889 · OSP
Promedic, Inc.
Obstetrics & Gynecology · 302d
Cleared Apr 23, 2014
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K132595 · HEB
Ontex Bvba
Obstetrics & Gynecology · 247d
Cleared Apr 23, 2014
XQ-1 INCUBATOR
K133742 · MQG
At Medical Uab
Obstetrics & Gynecology · 135d
Cleared Apr 22, 2014
INSTINCT
K132390 · HIS
Profilatex, S.A. DE C.V.
Obstetrics & Gynecology · 264d
Cleared Apr 21, 2014
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
K140761 · HES
Carefusion 2200, Inc.
Obstetrics & Gynecology · 26d